Demographic Characteristics, Baseline Clinical Symptoms, and Treatment Outcomes of Patients With TRD and Prominent Suicidal Ideation Receiving a Single Infusion of Ketamine vs Midazolam Placebo
| . | Patients with TRD having prominent suicidal ideation . | . | |
|---|---|---|---|
| . | Ketamine group (n = 42) . | Midazolam group (n = 42) . | P alue . |
| Age (SD), y | 34.26 (13.34) | 36.88 (12.21) | .351 |
| Female, n (%) | 28 (66.7) | 31 (73.8) | .634 |
| BMI (SD) | 25.48 (6.21) | 23.85 (4.95) | .186 |
| Education (SD), y | 14.43 (2.39) | 14.74 (2.72) | .581 |
| Age at illness onset (SD), y | 24.07 (9.71) | 24.43 (9.31) | .864 |
| History of attempted suicide, n (%) | 36 (85.7) | 38 (90.5) | .738 |
| No. of prior suicidal attempt, n (%) | .109 | ||
| Never | 6 (14.3) | 4 (9.6) | |
| 1 | 21 (50.0) | 14 (33.3) | |
| 2-4 | 5 (11.9) | 14 (33.3) | |
| ≥5 | 10 (23.8) | 10 (23.8) | |
| MSM, total scores (SD) | 9.86 (1.97) | 10.38 (1.64) | .189 |
| Treatment refractoriness, n (%) | .788 | ||
| Low | 4 (9.5) | 4 (9.5) | |
| Moderate | 19 (45.2) | 16 (38.1) | |
| High | 19 (45.2) | 22(52.4) | |
| Current episode, n (%) | .495 | ||
| <24 mo | 17 (40.5) | 13 (31.0) | |
| ≥24 mo | 25 (59.5) | 29 (69.0) | |
| Failure no. of antidepressants, n (%) | .379 | ||
| ≤4 | 21 (50.0) | 26 (61.9) | |
| >4 | 21 (50.0) | 16 (38.1) | |
| Clinical symptoms at baseline (SD) | |||
| MADRS | 35.83 (4.53) | 38.26 (3.83) | .010 |
| MADRS item 10 | 4.19 (0.40) | 4.26 (0.45) | .440 |
| CSSRS-ISS | 3.02 (0.81) | 3.10 (0.79) | .684 |
| PANSI-PSI | 12.21 (4.87) | 11.88 (4.53) | .746 |
| PANSI-NSI | 30.45 (7.06) | 29.55 (6.71) | .549 |
| Psychiatric comorbidities, n (%) | |||
| PTSD | 11 (26.2) | 11 (26.2) | >.999 |
| Panic disorder | 27 (64.3) | 26 (61.9) | >.999 |
| Generalized anxiety disorder | 32 (76.2) | 36 (85.7) | .405 |
| Treatment response based on at least once MADRS scores of ≥50% reduction at d 2 or 3 post infusion | .020 | ||
| Response, n (%) | 15 (35.7) | 5 (11.9) | |
| Nonresponse, n (%) | 27 (64.3) | 37 (88.1) | |
| Remission of suicidal ideation based on total CSSRS-ISS scores = 0 at post infusion | |||
| Day 1, 240 min | 14 (33.3) | 3 (7.1) | .005 |
| Day 2 | 14 (33.3) | 4 (9.5) | .015 |
| Day 3 | 14 (33.3) | 3 (7.1) | .005 |
| Day 5 | 11 (26.2) | 3 (7.1) | .038 |
| Day 7 | 8 (19.0) | 5 (11.9) | .548 |
| Day 14 | 7 (16.7) | 7 (16.7) | >.999 |
| Adverse effects during infusion, n (%) | |||
| Derealization | 29 (69.0) | 7 (16.7) | <.001 |
| Dizziness | 24 (57.1) | 5 (11.9) | <.001 |
| Nausea | 2 (4.8) | 4 (9.5) | .676 |
| Crying | 6 (14.3) | 0 (0.0) | .026 |
| Somnolence | 1 (2.4) | 0 (0.0) | >.999 |
| . | Patients with TRD having prominent suicidal ideation . | . | |
|---|---|---|---|
| . | Ketamine group (n = 42) . | Midazolam group (n = 42) . | P alue . |
| Age (SD), y | 34.26 (13.34) | 36.88 (12.21) | .351 |
| Female, n (%) | 28 (66.7) | 31 (73.8) | .634 |
| BMI (SD) | 25.48 (6.21) | 23.85 (4.95) | .186 |
| Education (SD), y | 14.43 (2.39) | 14.74 (2.72) | .581 |
| Age at illness onset (SD), y | 24.07 (9.71) | 24.43 (9.31) | .864 |
| History of attempted suicide, n (%) | 36 (85.7) | 38 (90.5) | .738 |
| No. of prior suicidal attempt, n (%) | .109 | ||
| Never | 6 (14.3) | 4 (9.6) | |
| 1 | 21 (50.0) | 14 (33.3) | |
| 2-4 | 5 (11.9) | 14 (33.3) | |
| ≥5 | 10 (23.8) | 10 (23.8) | |
| MSM, total scores (SD) | 9.86 (1.97) | 10.38 (1.64) | .189 |
| Treatment refractoriness, n (%) | .788 | ||
| Low | 4 (9.5) | 4 (9.5) | |
| Moderate | 19 (45.2) | 16 (38.1) | |
| High | 19 (45.2) | 22(52.4) | |
| Current episode, n (%) | .495 | ||
| <24 mo | 17 (40.5) | 13 (31.0) | |
| ≥24 mo | 25 (59.5) | 29 (69.0) | |
| Failure no. of antidepressants, n (%) | .379 | ||
| ≤4 | 21 (50.0) | 26 (61.9) | |
| >4 | 21 (50.0) | 16 (38.1) | |
| Clinical symptoms at baseline (SD) | |||
| MADRS | 35.83 (4.53) | 38.26 (3.83) | .010 |
| MADRS item 10 | 4.19 (0.40) | 4.26 (0.45) | .440 |
| CSSRS-ISS | 3.02 (0.81) | 3.10 (0.79) | .684 |
| PANSI-PSI | 12.21 (4.87) | 11.88 (4.53) | .746 |
| PANSI-NSI | 30.45 (7.06) | 29.55 (6.71) | .549 |
| Psychiatric comorbidities, n (%) | |||
| PTSD | 11 (26.2) | 11 (26.2) | >.999 |
| Panic disorder | 27 (64.3) | 26 (61.9) | >.999 |
| Generalized anxiety disorder | 32 (76.2) | 36 (85.7) | .405 |
| Treatment response based on at least once MADRS scores of ≥50% reduction at d 2 or 3 post infusion | .020 | ||
| Response, n (%) | 15 (35.7) | 5 (11.9) | |
| Nonresponse, n (%) | 27 (64.3) | 37 (88.1) | |
| Remission of suicidal ideation based on total CSSRS-ISS scores = 0 at post infusion | |||
| Day 1, 240 min | 14 (33.3) | 3 (7.1) | .005 |
| Day 2 | 14 (33.3) | 4 (9.5) | .015 |
| Day 3 | 14 (33.3) | 3 (7.1) | .005 |
| Day 5 | 11 (26.2) | 3 (7.1) | .038 |
| Day 7 | 8 (19.0) | 5 (11.9) | .548 |
| Day 14 | 7 (16.7) | 7 (16.7) | >.999 |
| Adverse effects during infusion, n (%) | |||
| Derealization | 29 (69.0) | 7 (16.7) | <.001 |
| Dizziness | 24 (57.1) | 5 (11.9) | <.001 |
| Nausea | 2 (4.8) | 4 (9.5) | .676 |
| Crying | 6 (14.3) | 0 (0.0) | .026 |
| Somnolence | 1 (2.4) | 0 (0.0) | >.999 |
Abbreviations: BMI, body mass index; CSSRS-ISS, Columbia-Suicide Severity Rating Scale-Ideation Severity Subscale; MADRS, Montgomery-Åsberg Depression Rating Scale; MSM, Maudsley Staging Method; NSI, Negative Suicide Ideation; PANSI, Positive and Negative Suicide Ideation Inventory; PSI, Positive Suicide Ideation; PTSD, posttraumatic stress disorder; TRD, treatment-resistant depression.
Bold type indicates the statistical significance.
Demographic Characteristics, Baseline Clinical Symptoms, and Treatment Outcomes of Patients With TRD and Prominent Suicidal Ideation Receiving a Single Infusion of Ketamine vs Midazolam Placebo
| . | Patients with TRD having prominent suicidal ideation . | . | |
|---|---|---|---|
| . | Ketamine group (n = 42) . | Midazolam group (n = 42) . | P alue . |
| Age (SD), y | 34.26 (13.34) | 36.88 (12.21) | .351 |
| Female, n (%) | 28 (66.7) | 31 (73.8) | .634 |
| BMI (SD) | 25.48 (6.21) | 23.85 (4.95) | .186 |
| Education (SD), y | 14.43 (2.39) | 14.74 (2.72) | .581 |
| Age at illness onset (SD), y | 24.07 (9.71) | 24.43 (9.31) | .864 |
| History of attempted suicide, n (%) | 36 (85.7) | 38 (90.5) | .738 |
| No. of prior suicidal attempt, n (%) | .109 | ||
| Never | 6 (14.3) | 4 (9.6) | |
| 1 | 21 (50.0) | 14 (33.3) | |
| 2-4 | 5 (11.9) | 14 (33.3) | |
| ≥5 | 10 (23.8) | 10 (23.8) | |
| MSM, total scores (SD) | 9.86 (1.97) | 10.38 (1.64) | .189 |
| Treatment refractoriness, n (%) | .788 | ||
| Low | 4 (9.5) | 4 (9.5) | |
| Moderate | 19 (45.2) | 16 (38.1) | |
| High | 19 (45.2) | 22(52.4) | |
| Current episode, n (%) | .495 | ||
| <24 mo | 17 (40.5) | 13 (31.0) | |
| ≥24 mo | 25 (59.5) | 29 (69.0) | |
| Failure no. of antidepressants, n (%) | .379 | ||
| ≤4 | 21 (50.0) | 26 (61.9) | |
| >4 | 21 (50.0) | 16 (38.1) | |
| Clinical symptoms at baseline (SD) | |||
| MADRS | 35.83 (4.53) | 38.26 (3.83) | .010 |
| MADRS item 10 | 4.19 (0.40) | 4.26 (0.45) | .440 |
| CSSRS-ISS | 3.02 (0.81) | 3.10 (0.79) | .684 |
| PANSI-PSI | 12.21 (4.87) | 11.88 (4.53) | .746 |
| PANSI-NSI | 30.45 (7.06) | 29.55 (6.71) | .549 |
| Psychiatric comorbidities, n (%) | |||
| PTSD | 11 (26.2) | 11 (26.2) | >.999 |
| Panic disorder | 27 (64.3) | 26 (61.9) | >.999 |
| Generalized anxiety disorder | 32 (76.2) | 36 (85.7) | .405 |
| Treatment response based on at least once MADRS scores of ≥50% reduction at d 2 or 3 post infusion | .020 | ||
| Response, n (%) | 15 (35.7) | 5 (11.9) | |
| Nonresponse, n (%) | 27 (64.3) | 37 (88.1) | |
| Remission of suicidal ideation based on total CSSRS-ISS scores = 0 at post infusion | |||
| Day 1, 240 min | 14 (33.3) | 3 (7.1) | .005 |
| Day 2 | 14 (33.3) | 4 (9.5) | .015 |
| Day 3 | 14 (33.3) | 3 (7.1) | .005 |
| Day 5 | 11 (26.2) | 3 (7.1) | .038 |
| Day 7 | 8 (19.0) | 5 (11.9) | .548 |
| Day 14 | 7 (16.7) | 7 (16.7) | >.999 |
| Adverse effects during infusion, n (%) | |||
| Derealization | 29 (69.0) | 7 (16.7) | <.001 |
| Dizziness | 24 (57.1) | 5 (11.9) | <.001 |
| Nausea | 2 (4.8) | 4 (9.5) | .676 |
| Crying | 6 (14.3) | 0 (0.0) | .026 |
| Somnolence | 1 (2.4) | 0 (0.0) | >.999 |
| . | Patients with TRD having prominent suicidal ideation . | . | |
|---|---|---|---|
| . | Ketamine group (n = 42) . | Midazolam group (n = 42) . | P alue . |
| Age (SD), y | 34.26 (13.34) | 36.88 (12.21) | .351 |
| Female, n (%) | 28 (66.7) | 31 (73.8) | .634 |
| BMI (SD) | 25.48 (6.21) | 23.85 (4.95) | .186 |
| Education (SD), y | 14.43 (2.39) | 14.74 (2.72) | .581 |
| Age at illness onset (SD), y | 24.07 (9.71) | 24.43 (9.31) | .864 |
| History of attempted suicide, n (%) | 36 (85.7) | 38 (90.5) | .738 |
| No. of prior suicidal attempt, n (%) | .109 | ||
| Never | 6 (14.3) | 4 (9.6) | |
| 1 | 21 (50.0) | 14 (33.3) | |
| 2-4 | 5 (11.9) | 14 (33.3) | |
| ≥5 | 10 (23.8) | 10 (23.8) | |
| MSM, total scores (SD) | 9.86 (1.97) | 10.38 (1.64) | .189 |
| Treatment refractoriness, n (%) | .788 | ||
| Low | 4 (9.5) | 4 (9.5) | |
| Moderate | 19 (45.2) | 16 (38.1) | |
| High | 19 (45.2) | 22(52.4) | |
| Current episode, n (%) | .495 | ||
| <24 mo | 17 (40.5) | 13 (31.0) | |
| ≥24 mo | 25 (59.5) | 29 (69.0) | |
| Failure no. of antidepressants, n (%) | .379 | ||
| ≤4 | 21 (50.0) | 26 (61.9) | |
| >4 | 21 (50.0) | 16 (38.1) | |
| Clinical symptoms at baseline (SD) | |||
| MADRS | 35.83 (4.53) | 38.26 (3.83) | .010 |
| MADRS item 10 | 4.19 (0.40) | 4.26 (0.45) | .440 |
| CSSRS-ISS | 3.02 (0.81) | 3.10 (0.79) | .684 |
| PANSI-PSI | 12.21 (4.87) | 11.88 (4.53) | .746 |
| PANSI-NSI | 30.45 (7.06) | 29.55 (6.71) | .549 |
| Psychiatric comorbidities, n (%) | |||
| PTSD | 11 (26.2) | 11 (26.2) | >.999 |
| Panic disorder | 27 (64.3) | 26 (61.9) | >.999 |
| Generalized anxiety disorder | 32 (76.2) | 36 (85.7) | .405 |
| Treatment response based on at least once MADRS scores of ≥50% reduction at d 2 or 3 post infusion | .020 | ||
| Response, n (%) | 15 (35.7) | 5 (11.9) | |
| Nonresponse, n (%) | 27 (64.3) | 37 (88.1) | |
| Remission of suicidal ideation based on total CSSRS-ISS scores = 0 at post infusion | |||
| Day 1, 240 min | 14 (33.3) | 3 (7.1) | .005 |
| Day 2 | 14 (33.3) | 4 (9.5) | .015 |
| Day 3 | 14 (33.3) | 3 (7.1) | .005 |
| Day 5 | 11 (26.2) | 3 (7.1) | .038 |
| Day 7 | 8 (19.0) | 5 (11.9) | .548 |
| Day 14 | 7 (16.7) | 7 (16.7) | >.999 |
| Adverse effects during infusion, n (%) | |||
| Derealization | 29 (69.0) | 7 (16.7) | <.001 |
| Dizziness | 24 (57.1) | 5 (11.9) | <.001 |
| Nausea | 2 (4.8) | 4 (9.5) | .676 |
| Crying | 6 (14.3) | 0 (0.0) | .026 |
| Somnolence | 1 (2.4) | 0 (0.0) | >.999 |
Abbreviations: BMI, body mass index; CSSRS-ISS, Columbia-Suicide Severity Rating Scale-Ideation Severity Subscale; MADRS, Montgomery-Åsberg Depression Rating Scale; MSM, Maudsley Staging Method; NSI, Negative Suicide Ideation; PANSI, Positive and Negative Suicide Ideation Inventory; PSI, Positive Suicide Ideation; PTSD, posttraumatic stress disorder; TRD, treatment-resistant depression.
Bold type indicates the statistical significance.
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